Dialysis, Anemia
Conditions
Keywords
Kidney, ESRD, Renal, End-Stage Renal Disease, Anemia, Oral anemia treatment, Hemoglobin levels, Hemodialysis, Peritoneal, HD, PD, Hb, Erythropoietin, Blood count
Brief summary
The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.
Detailed description
Participants on hemodialysis (HD) will be randomized to 3 treatment arms (A, B, and C) of in a 1:1:1 ratio to receive no iron supplementation, oral iron supplementation, and IV iron supplementation, respectively, in addition to roxadustat. At the same time, participants on peritoneal dialysis (PD) will be enrolled into Arm D. Arm E will enroll either HD or PD participants, and is an optional, confirmatory/supplemental treatment arm with flexible dosing and flexible iron supplementation based on the evaluation of data from the previous 4 treatment arms. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low weight \[40 to 60 kilograms {kg}\], medium weight \[\>60 to 90 kg\], and heavy weight \[\>90 to 140 kg\] participants will receive 60, 100, and 140 milligrams \[mg\] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 140, 200, and 300 mg for low, medium, and high weight participants, respectively) during Weeks 5 and 9, depending on the hemoglobin (Hb) level and rate of Hb rise in the previous 4 weeks.
Interventions
Sponsors
Astellas Pharma Inc
Kyntra Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4 months, prior to randomization * Mean of the 2 most recent Hb values during the screening period, obtained at least 7 days apart, must be \<10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL between the 2 values * Body weight 40 to 140 kilograms (kg)
Exclusion criteria
* Previously received erythropoiesis-stimulating agents * Received IV iron within 4 weeks of randomization * Received red blood cell transfusion within 8 weeks prior to randomization or anticipated need for transfusion during the treatment period * Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab) * History of chronic liver disease * Clinically significant infection * New York Heart Association Class III or IV congestive heart failure * History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps * Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission * History of other blood disorders * Active hemolysis or diagnosis of hemolytic syndrome * Known bone marrow fibrosis * Uncontrolled or symptomatic secondary hyperparathyroidism * History of alcohol or drug abuse within a year prior to randomization, or anticipated inability to avoid consumption of more than 3 alcoholic beverages per day * History of allergy or sensitivity to oral or IV iron therapy * Seizure disorder or receiving anti-epilepsy medication for seizure disorder within 12 weeks prior to randomization * Pregnant or breast-feeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL | Week 3 to 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL | Week 3 to 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Weeks 5, 9, and 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | Weeks 3-13 | — |
| Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline, Weeks 3-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: \<1 g/dL, ≥1 g/dL, 1 to \<2 g/dL, 2 to \<3 g/dL, \>3 to \<4 g/dL, ≥4 g/dL. |
| Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline up to Week 13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Weeks 5 and 9 | Number of participants requiring dose increase due to any reasons is reported. |
| Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Weeks 5 and 9 | Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported. |
| Change From Baseline in Ferritin at Week 13 | Baseline, Week 13 | Baseline was defined as the average of the last 2 values prior to the first dose administration. |
| Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Baseline, Week 13 | — |
| Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Baseline, Week 13 | — |
| Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline, Weeks 2-5, 6-9, and 10-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. |
| Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL | Weeks 10-13 | — |
| Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL | Weeks 10-13 | — |
| Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 and 10-13 | — |
| Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 and 10-13 | — |
| Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Baseline up to Week 13 | Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported. |
| Number of Participants Requiring Therapeutic Phlebotomy | Baseline up to Week 13 | Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported. |
| Number of Participants Withdrawn From the Study Due to Inadequate Efficacy | Baseline up to Week 16 | Number of participants withdrawn from the study due to inadequate efficacy is reported. |
| Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Baseline, Weeks 9 and 13 | The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). Higher score indicated a better health state. Baseline is defined as the last non-missing value prior to the first dose administration. |
| Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Baseline, Weeks 9 and 13 | FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration. |
| Number of Participants With Potentially Clinically Significant Laboratory Tests | Baseline up to Week 16 | Criteria for the potential clinical significance included: bilirubin (µmol/L) \>1.5 \* upper limit of normal (ULN), potassium (mmol/L) \>1.2 \* ULN, neutrophils (\*10\^9/L) ≤1, protein (g/L) \>1.1 \* ULN, leukocytes (\*10\^9/L) ≤2.5 or ≥15. |
| Number of Participants With TEAEs | Baseline up to Week 16 | An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 and 10-13 | — |
Countries
Hong Kong, Russia, Singapore, United States
Participant flow
Recruitment details
Participants on hemodialysis (HD) were randomized to one of the 3 arms A, B, or C in 1:1:1 ratio to receive roxadustat with either no, per oral (PO), or intravenous (IV) iron supplementation, respectively. Participants on peritoneal dialysis (PD) were enrolled into Arm D and received roxadustat with PO iron supplementation.
Pre-assignment details
Arm E was an optional, confirmatory/supplemental arm with flexible dosing and flexible iron supplementation based on the evaluation of data from the previous 4 arms. After enrollment of Arms A through C was completed, Arm E was decided to be identical to Arm A, for example, roxadustat with no iron supplementation and with the same tiered weight-based initial dosing. Hence, the data of Arms A and E were reported in a single arm.
Participants by arm
| Arm | Count |
|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | 24 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | 12 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks. | 12 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks. | 12 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 0 |
| Overall Study | Death | 1 | 0 | 0 | 1 |
| Overall Study | Other than specified | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Arm A + E (Participants on HD): Roxadustat Only, No Iron | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.6 years STANDARD_DEVIATION 17.7 | 46.8 years STANDARD_DEVIATION 14.6 | 53.1 years STANDARD_DEVIATION 12.6 | 51.4 years STANDARD_DEVIATION 12.4 | 50.1 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 7 Participants | 10 Participants | 29 Participants |
| Sex: Female, Male Male | 15 Participants | 9 Participants | 5 Participants | 2 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 24 | 4 / 12 | 0 / 12 | 2 / 12 |
| serious Total, serious adverse events | 3 / 24 | 1 / 12 | 0 / 12 | 3 / 12 |
Outcome results
Primary
Maximum Change From Baseline in Hb During Weeks 3-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.
Time frame: Baseline, Weeks 3-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline | 8.1 grams/deciliter (g/dL) | Standard Error 0.2 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Maximum Change From Baseline in Hb During Weeks 3-13 | Change at Weeks 3-13 | 2.8 grams/deciliter (g/dL) | Standard Error 0.2 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Maximum Change From Baseline in Hb During Weeks 3-13 | Change at Weeks 3-13 | 3.5 grams/deciliter (g/dL) | Standard Error 0.5 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline | 8.5 grams/deciliter (g/dL) | Standard Error 0.3 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline | 8.4 grams/deciliter (g/dL) | Standard Error 0.3 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Maximum Change From Baseline in Hb During Weeks 3-13 | Change at Weeks 3-13 | 3.5 grams/deciliter (g/dL) | Standard Error 0.4 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Maximum Change From Baseline in Hb During Weeks 3-13 | Baseline | 8.7 grams/deciliter (g/dL) | Standard Error 0.2 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Maximum Change From Baseline in Hb During Weeks 3-13 | Change at Weeks 3-13 | 3.3 grams/deciliter (g/dL) | Standard Error 0.2 |
Comparison: Analysis of covariance (ANCOVA) model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.p-value: 0.0757ANCOVA
Comparison: ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.p-value: 0.063ANCOVA
Comparison: ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.p-value: 0.8653ANCOVA
Comparison: ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.p-value: 0.8982ANCOVA
Secondary
Change From Baseline in Ferritin at Week 13
Baseline was defined as the average of the last 2 values prior to the first dose administration.
Time frame: Baseline, Week 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Ferritin at Week 13 | Baseline | 156.4 micrograms/liter (µg/L) | Standard Error 12.9 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Ferritin at Week 13 | Change at Week 13 | -119.7 micrograms/liter (µg/L) | Standard Error 12.2 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Ferritin at Week 13 | Change at Week 13 | -51.1 micrograms/liter (µg/L) | Standard Error 25.2 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Ferritin at Week 13 | Baseline | 162.5 micrograms/liter (µg/L) | Standard Error 30.8 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Ferritin at Week 13 | Baseline | 182.0 micrograms/liter (µg/L) | Standard Error 27.4 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Ferritin at Week 13 | Change at Week 13 | -25.2 micrograms/liter (µg/L) | Standard Error 33.5 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Ferritin at Week 13 | Baseline | 137.4 micrograms/liter (µg/L) | Standard Error 27 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Ferritin at Week 13 | Change at Week 13 | -65.1 micrograms/liter (µg/L) | Standard Error 29.4 |
Secondary
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13
FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration.
Time frame: Baseline, Weeks 9 and 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Change at Week 13 | 7.3 units on a scale | Standard Error 4.3 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Baseline | 123.5 units on a scale | Standard Error 6.8 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Change at Week 9 | 8.2 units on a scale | Standard Error 4.5 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Change at Week 13 | 5.9 units on a scale | Standard Error 6.9 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Change at Week 9 | 4.0 units on a scale | Standard Error 7.2 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Baseline | 118.9 units on a scale | Standard Error 10.9 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Baseline | 128.8 units on a scale | Standard Error 11.3 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Change at Week 9 | 1.9 units on a scale | Standard Error 9.8 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Change at Week 13 | 5.1 units on a scale | Standard Error 8.9 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Change at Week 13 | 12.9 units on a scale | Standard Error 7.4 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Baseline | 122.8 units on a scale | Standard Error 7.9 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Change at Week 9 | 12.8 units on a scale | Standard Error 6.9 |
Secondary
Change From Baseline in Reticulocyte Hemoglobin Content at Week 13
Time frame: Baseline, Week 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Baseline | 31.0 picogram (pg) | Standard Error 0.3 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Change at Week 13 | -2.2 picogram (pg) | Standard Error 0.7 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Change at Week 13 | -1.9 picogram (pg) | Standard Error 0.9 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Baseline | 31.6 picogram (pg) | Standard Error 0.5 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Baseline | 31.5 picogram (pg) | Standard Error 0.5 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Change at Week 13 | -1.0 picogram (pg) | Standard Error 0.6 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Baseline | 30.4 picogram (pg) | Standard Error 0.4 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | Change at Week 13 | -0.2 picogram (pg) | Standard Error 0.6 |
Secondary
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13
The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). Higher score indicated a better health state. Baseline is defined as the last non-missing value prior to the first dose administration.
Time frame: Baseline, Weeks 9 and 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Baseline | 38.8 units on a scale | Standard Error 2.3 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Change at Week 9 | 2.9 units on a scale | Standard Error 1.8 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Baseline | 46.3 units on a scale | Standard Error 2.2 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Change at Week 9 | 4.8 units on a scale | Standard Error 1.6 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Change at Week 13 | 3.9 units on a scale | Standard Error 1.7 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Change at Week 13 | 5.2 units on a scale | Standard Error 1.8 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Change at Week 13 | 1.8 units on a scale | Standard Error 2.1 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Change at Week 9 | 1.6 units on a scale | Standard Error 2.5 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Change at Week 9 | -1.0 units on a scale | Standard Error 4 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Baseline | 48.2 units on a scale | Standard Error 4.1 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Baseline | 40.7 units on a scale | Standard Error 3.2 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Change at Week 13 | 1.6 units on a scale | Standard Error 3.7 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Baseline | 41.2 units on a scale | Standard Error 3.4 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Baseline | 49.0 units on a scale | Standard Error 3.5 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Change at Week 9 | 1.5 units on a scale | Standard Error 2.5 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Change at Week 13 | 4.8 units on a scale | Standard Error 1.8 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Change at Week 9 | 3.4 units on a scale | Standard Error 2.8 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Change at Week 13 | 3.1 units on a scale | Standard Error 2.3 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Change at Week 13 | 6.2 units on a scale | Standard Error 1.6 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Change at Week 9 | 5.9 units on a scale | Standard Error 3 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Change at Week 9 | 3.4 units on a scale | Standard Error 1.2 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Baseline | 40.8 units on a scale | Standard Error 1.8 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Vitality subscore: Baseline | 46.8 units on a scale | Standard Error 3.6 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Physical functioning subscore: Change at Week 13 | 2.3 units on a scale | Standard Error 1.3 |
Secondary
Change From Baseline in Transferrin Saturation (TSAT) at Week 13
Time frame: Baseline, Week 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Baseline | 18.8 percentage of transferrin | Standard Error 0.8 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Change at Week 13 | -7.4 percentage of transferrin | Standard Error 1.4 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Change at Week 13 | 2.6 percentage of transferrin | Standard Error 2.5 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Baseline | 19.0 percentage of transferrin | Standard Error 1 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Baseline | 18.1 percentage of transferrin | Standard Error 1.5 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Change at Week 13 | 0.7 percentage of transferrin | Standard Error 2.9 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Baseline | 19.3 percentage of transferrin | Standard Error 1.8 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | Change at Week 13 | -1.6 percentage of transferrin | Standard Error 2.6 |
Secondary
Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Time frame: Baseline, Weeks 2-5, 6-9, and 10-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 10-13 | 2.1 g/dL | Standard Error 0.2 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline | 8.1 g/dL | Standard Error 0.2 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 6-9 | 2.0 g/dL | Standard Error 0.2 |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 2-5 | 1.1 g/dL | Standard Error 0.1 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 6-9 | 2.3 g/dL | Standard Error 0.4 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline | 8.5 g/dL | Standard Error 0.3 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 2-5 | 1.1 g/dL | Standard Error 0.2 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 10-13 | 2.7 g/dL | Standard Error 0.5 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 6-9 | 2.0 g/dL | Standard Error 0.4 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 10-13 | 3.0 g/dL | Standard Error 0.4 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline | 8.4 g/dL | Standard Error 0.3 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 2-5 | 1.0 g/dL | Standard Error 0.2 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 2-5 | 0.8 g/dL | Standard Error 0.3 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 6-9 | 1.8 g/dL | Standard Error 0.4 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline | 8.7 g/dL | Standard Error 0.2 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Change at Weeks 10-13 | 2.4 g/dL | Standard Error 0.2 |
Secondary
Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Time frame: Baseline up to Week 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | 4.0 weeks |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | 4.0 weeks |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | 4.0 weeks |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | 4.0 weeks |
Secondary
Number of Participants Requiring Dose Increase at Weeks 5 and 9
Number of participants requiring dose increase due to any reasons is reported.
Time frame: Weeks 5 and 9
Population: Safety population included all participants who received any dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Week 5 | 2 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Week 9 | 8 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Week 9 | 5 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Week 5 | 3 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Week 5 | 2 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Week 9 | 3 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Week 5 | 4 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Week 9 | 5 Participants |
Secondary
Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis
Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported.
Time frame: Weeks 5 and 9
Population: Safety population included all participants who received any dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose reduced at Week 5 | 3 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose interrupted at Week 5 | 1 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose reduced at Week 9 | 1 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose interrupted at Week 9 | 1 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose interrupted at Week 5 | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose reduced at Week 9 | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose interrupted at Week 9 | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose reduced at Week 5 | 5 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose reduced at Week 9 | 3 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose interrupted at Week 5 | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose interrupted at Week 9 | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose reduced at Week 5 | 3 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose interrupted at Week 9 | 1 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose interrupted at Week 5 | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose reduced at Week 5 | 5 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Dose reduced at Week 9 | 0 Participants |
Secondary
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C)
Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported.
Time frame: Baseline up to Week 13
Population: Safety population included all participants who received any dose of study drug. Here 'Number analyzed' signifies participants evaluable for specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Blood transfusion for gastrointestinal bleeding | 1 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | IV iron for a treatment-emergent adverse event (TEAE) of thrombocytosis | 1 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | IV iron for acute iron deficiency | 1 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Blood transfusion for severe anemia | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | IV iron for acute iron deficiency | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | IV iron for a treatment-emergent adverse event (TEAE) of thrombocytosis | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Blood transfusion for gastrointestinal bleeding | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Blood transfusion for severe anemia | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Blood transfusion for gastrointestinal bleeding | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Blood transfusion for severe anemia | 1 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | IV iron for a treatment-emergent adverse event (TEAE) of thrombocytosis | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Blood transfusion for severe anemia | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Blood transfusion for gastrointestinal bleeding | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | IV iron for acute iron deficiency | 0 Participants |
Secondary
Number of Participants Requiring Therapeutic Phlebotomy
Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported.
Time frame: Baseline up to Week 13
Population: Safety population included all participants who received any dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Therapeutic Phlebotomy | 1 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
Secondary
Number of Participants Who Achieved Maximum Hb During Weeks 3-13
Time frame: Weeks 3-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | >13 to 14 g/dL | 0 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | 10 to <11 g/dL | 7 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | >14 g/dL | 0 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | 11 to 13 g/dL | 10 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | <10 g/dL | 6 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | 11 to 13 g/dL | 5 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | >13 to 14 g/dL | 1 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | >14 g/dL | 2 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | 10 to <11 g/dL | 3 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | <10 g/dL | 1 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | 11 to 13 g/dL | 5 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | <10 g/dL | 2 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | 10 to <11 g/dL | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | >13 to 14 g/dL | 3 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | >14 g/dL | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | >13 to 14 g/dL | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | 10 to <11 g/dL | 1 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | <10 g/dL | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | 11 to 13 g/dL | 9 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | >14 g/dL | 0 Participants |
Secondary
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Time frame: Week 3 to 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL | 17 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL | 10 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL | 8 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL | 10 Participants |
Secondary
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Time frame: Week 3 to 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL | 10 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL | 8 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL | 8 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL | 9 Participants |
Secondary
Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Time frame: Weeks 5, 9, and 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 5 | 21 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 13 | 22 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 9 | 22 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 5 | 9 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 13 | 11 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 9 | 10 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 9 | 9 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 5 | 7 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 13 | 10 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 5 | 7 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 13 | 10 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 | Week 9 | 9 Participants |
Secondary
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: \<1 g/dL, ≥1 g/dL, 1 to \<2 g/dL, 2 to \<3 g/dL, \>3 to \<4 g/dL, ≥4 g/dL.
Time frame: Baseline, Weeks 3-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | <1 g/dL | 1 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | ≥1 g/dL | 22 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 1 to <2 g/dL | 4 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 2 to <3 g/dL | 9 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | >3 to <4 g/dL | 7 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | ≥4 g/dL | 2 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | ≥4 g/dL | 5 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 2 to <3 g/dL | 2 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | <1 g/dL | 1 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 1 to <2 g/dL | 2 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | ≥1 g/dL | 11 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | >3 to <4 g/dL | 2 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | ≥1 g/dL | 10 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 1 to <2 g/dL | 2 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 2 to <3 g/dL | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | ≥4 g/dL | 4 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | >3 to <4 g/dL | 4 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | <1 g/dL | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | >3 to <4 g/dL | 3 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | ≥4 g/dL | 2 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | ≥1 g/dL | 10 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 2 to <3 g/dL | 5 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | <1 g/dL | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 1 to <2 g/dL | 0 Participants |
Secondary
Number of Participants Withdrawn From the Study Due to Inadequate Efficacy
Number of participants withdrawn from the study due to inadequate efficacy is reported.
Time frame: Baseline up to Week 16
Population: Safety population included all participants who received any dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
Secondary
Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13
Time frame: Weeks 6-9 and 10-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Week 6-9 | 10 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Week 10-13 | 8 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Week 10-13 | 3 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Week 6-9 | 4 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Week 6-9 | 2 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Week 10-13 | 2 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Week 6-9 | 3 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | Week 10-13 | 1 Participants |
Secondary
Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13
Time frame: Weeks 6-9 and 10-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 | 6 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 10-13 | 5 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 10-13 | 2 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 | 5 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 | 4 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 10-13 | 5 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 6-9 | 5 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | Weeks 10-13 | 7 Participants |
Secondary
Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13
Time frame: Weeks 6-9 and 10-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Week 6-9 | 0 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Week 10-13 | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Week 10-13 | 1 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Week 6-9 | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Week 6-9 | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Week 10-13 | 1 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Week 6-9 | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | Week 10-13 | 0 Participants |
Secondary
Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL
Time frame: Weeks 10-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants with maximum Hb ≥10 g/dL and change of Hb ≥1 g/dL during Weeks 10-13. LOCF method was used to impute missing values.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL | 15 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL | 7 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL | 7 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL | 9 Participants |
Secondary
Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL
Time frame: Weeks 10-13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants with maximum Hb ≥11 g/dL and change of Hb ≥1 g/dL during Weeks 10-13. LOCF method was used to impute missing values.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL | 5 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL | 2 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL | 5 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL | 7 Participants |
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Tests
Criteria for the potential clinical significance included: bilirubin (µmol/L) \>1.5 \* upper limit of normal (ULN), potassium (mmol/L) \>1.2 \* ULN, neutrophils (\*10\^9/L) ≤1, protein (g/L) \>1.1 \* ULN, leukocytes (\*10\^9/L) ≤2.5 or ≥15.
Time frame: Baseline up to Week 16
Population: Safety population included all participants who received any dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Potentially Clinically Significant Laboratory Tests | Neutrophils | 0 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Potentially Clinically Significant Laboratory Tests | Potassium | 2 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Potentially Clinically Significant Laboratory Tests | Protein | 1 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Potentially Clinically Significant Laboratory Tests | Leukocytes | 1 Participants |
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With Potentially Clinically Significant Laboratory Tests | Bilirubin | 1 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Neutrophils | 1 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Bilirubin | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Potassium | 1 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Protein | 0 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Leukocytes | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Bilirubin | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Neutrophils | 1 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Potassium | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Protein | 0 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Leukocytes | 1 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Potassium | 1 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Protein | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Neutrophils | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Bilirubin | 0 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With Potentially Clinically Significant Laboratory Tests | Leukocytes | 0 Participants |
Secondary
Number of Participants With TEAEs
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Week 16
Population: Safety population included all participants who received any dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Number of Participants With TEAEs | 16 Participants |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With TEAEs | 6 Participants |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Number of Participants With TEAEs | 3 Participants |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Number of Participants With TEAEs | 5 Participants |
Secondary
Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.
Time frame: Baseline up to Week 13
Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | 4.2 mg/kg | Standard Deviation 0.5 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | 4.2 mg/kg | Standard Deviation 1.2 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | 4.5 mg/kg | Standard Deviation 1.4 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | 4.3 mg/kg | Standard Deviation 1.4 |